Clinical Utility of a Circulating Tumor Cell Based Test for Cancer Detection and Diagnosis

Diagnosis of most types of cancers in symptomatic individuals is based on Histopathological Evaluation (HPE) of tumor tissue or other biological specimen (e.g., bone marrow aspirate) obtained by an invasive biopsy. Such biopsies are specialized invasive procedures with significant morbidity and financial implications. In addition, they necessitate patient’s visits to a tertiary care center with specialized facilities. Apart from the logistical aspects, there are other factors which impact tumor tissue procurement such as inaccessibility of the tumor, proximity of the tumor to vital organs or vasculature, patients’ comorbidities or even patients’ reluctance due to procedural risks. Repeat biopsies may oftentimes be desirable such as (a) where the prior tissue sample was insufficient or poorly representative or (b) for determining status of therapeutically relevant biomarkers or (c) for characterization of recurrent lesions or (d) for identification of a new lesion as a second primary or metastasis. However, repeat biopsies are associated with increased procedural risks.

This is a blinded, prospective, observational study to evaluate the clinical utility and performance of a CTC based test for detection and localization of brain, breast, lung, prostate, pancreas, bile duct or gallbladder cancer. The study objective is to determine the performance characteristics of the test for detection and localization of brain, breast, lung, prostate, pancreas, bile duct or gallbladder cancer. The study population includes adult males and females presenting with symptoms or clinical / radiological findings, suspected of brain, breast, lung, prostate, pancreas, bile duct or gallbladder cancer. For enrollment, priority will be given to individuals suspected of early-stage disease (localized to primary organ, no lymph node involvement) in case of breast, lung, prostate, pancreas, bile duct or gallbladder cancers. A cumulative enrollment of 850 individuals is planned. The study investigator or an authorized representative will identify individuals eligible for the study, based on the inclusion/exclusion criteria. After providing all necessary information related to study, and after obtaining written informed consent from eligible participants, 15 ml blood will be drawn from all participants as per study protocol. On the completion of the cohorts, data will be analyzed to evaluate the study objectives.